FDA.reportPublic FDA data

PT. SMART GLOVE INDONESIA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30035918363003591836PT. SMART GLOVE INDONESIA1N2020-04-25JL PELITA RAYA NO 5-7, KAWASAN INDUSTRI MEDAN STAR JL RAYA MEDAN-LUBUK PAKAM KM 19, TANJUNG MORAWA DELI SERDANG Sumatera Utara ID 20362

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
205301559396908K981349SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVESLZA1998-05-18
205301101293537K133699POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVESLZA2014-07-18
205301709800155K110921NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2011-04-15
205301168141520K101630POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUELZA2010-09-07
205301423575486K101293POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)LZA2010-07-01
205301606567993K092034POWDER FREE NITRILE EXAMINATION GLOVES, BLACKLZA2009-10-19
205301414370340K081315POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT)LZA2008-08-11
205301758323125K080937POWDER FREE NITRILE EXAMINATION GLOVE, ORANGELZA2008-05-23
205301562796016K071119POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE)LZA2007-07-24
205301452779777K041848POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLORLZA2004-08-20
205301349210122K040792POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)LYY2004-08-12
205301586277265K040791POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)LZA2004-06-03
205302042731451K030406NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVORLZA2003-02-27
205301277967031K030284POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)LZA2003-03-25
205302018785742K030112POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLYY2003-02-27
205301060100395K022815MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEXLYY2003-02-13
205301767842041K022814MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)LZA2003-02-19
205301984229603K022765NITRILE POWDER-FREE EXAMINATION GLOVESLZA2002-10-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA152014-07-18
LYY32004-08-12

PMN#